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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05357222
Other study ID # IRB_00141650
Secondary ID R01DC018280
Status Recruiting
Phase N/A
First received
Last updated
Start date November 16, 2021
Est. completion date August 1, 2025

Study information

Verified date November 2023
Source University of Utah
Contact Lynn Maxfield, PhD
Phone 801-596-2012
Email lynn.maxfield@utah.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate the change in fundamental frequency range and vocal fold stability achievable with vocal fold stretching exercise in human populations with high and low vocal activity


Description:

The vocal ligament is part of the layered structure of the vocal fold. It is a thin band of tissue near the superior medial edge of the vocal fold. The cord-like appearance of the ligament gave rise to the traditional term "vocal cord". The ligament connects the arytenoid cartilage (lower broad dark region) to the anterior portion of the thyroid cartilage (upper dark region). The slightly thickened endpoints are known as the anterior and posterior macula flava. In the medial-lateral direction, the vocal ligament comprises the intermediate and deep layer of the lamina propria. The physiological functions of the vocal ligament are not fully understood. One function is to limit mechanical strain (elongation), a general function of most ligaments in the body. A second function may be to produce a firm closure of the glottis by forming a straight edge along the membranous (vibrating) portion of the vocal fold. A strong ligament that can be tensed with exercise is likely to help straighten the edge of the folds. Vocal fold bowing, for example, is a pathological condition often associated with advanced age, but it can also occur in young adults who press their arytenoid cartilages together excessively in speech. Atrophy of the thyroarytenoid muscle, which lies lateral to the ligament, causes the middle of the membranous vocal fold to be retracted from the midline of the glottis. The result is a weak voice because airflow cannot be suddenly shut off for efficient acoustic excitation of the vocal tract. For self-sustained vocal fold vibration, the superficial layer must be very pliable and deformable for mucosal surface-wave motion. The role of the ligament is then to stabilize the vertical motion when large pressures are applied to vocal fold surfaces. The most important known function of the ligament, however, is to widen the fundamental frequency range. The stiffer the ligament, the greater the likelihood that several octaves of fo range can be achieved.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants must be 18 years or older - no current voice disorder - no history of performance or professional vocal training Exclusion Criteria: - history of head/neck cancer, laryngeal surgery, current voice disorder requiring medical management - cognitive limitations that would prevent them from successfully and safely participating in the study. - history of gastrointestinal disease or surgery w - no known neurological or structural abnormalities of vocal folds - previous laryngeal surgeries; - allergies to local anesthetics (used to suppress a sensitive gag reflex during laryngeal endoscopic examination); - cardiac abnormalities; - recent history of smoking (must be completely smoke-free for six months prior to study commencement because of the effect of smoking on the voice and laryngopharyngeal reflux severity).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Straw phontion
Pitch Glides: (1 minute) Vocalize through the straw starting from as low as possible to as high as possible. As the participant you will want to get as much as your vocal range as possible. But, don't let the voice get growly at the bottom or press it into a painful range at the top. 2. Accents: (1 minute) Vocalize progressive little hills or accents. It sounds like a revving engine of the car. 3. Song: (1 minute) Pick a favorite song and vocalize it through the straw. Examples: National Anthem, Happy Birthday, Mary had a Little Lamb. These are great songs because they have a range of pitches and one can build some accents in, as well. 4. Reading passage: (1 minute) Vocalize a reading passage through the straw. Be as dramatic as possible, using a lot of inflection.

Locations

Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (2)

Lead Sponsor Collaborator
University of Utah National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Voice Range Profile (VRP) a thorough voice range profile will be created by testing the participants lowest (minimum) and highest (maximum) achievable pitches across a spectrum of vocal intensities (soft, medium and loud). pre-intervention (initial evaluation)
Primary Voice Range Profile (VRP) a thorough voice range profile will be created by testing the participants lowest (minimum) and highest (maximum) achievable pitches across a spectrum of vocal intensities (soft, medium and loud). 8 weeks post intervention
Primary Voice Range Profile (VRP) a thorough voice range profile will be created by testing the participants lowest (minimum) and highest (maximum) achievable pitches across a spectrum of vocal intensities (soft, medium and loud). 3 months following intervention
Secondary Electroglottography (EGG) Electroglottograph, or EGG, is a device used for the noninvasive measurement of the degree of contact between the vibrating vocal folds during voice production. Electrodes are applied on the surface of the neck so that the EGG records variations in the transverse electrical impedance of the larynx can be measured. pre-intervention
Secondary Electroglottography (EGG) Electroglottograph, or EGG, is a device used for the noninvasive measurement of the degree of contact between the vibrating vocal folds during voice production. Electrodes are applied on the surface of the neck so that the EGG records variations in the transverse electrical impedance of the larynx can be measured. 8 weeks post intervention
Secondary Electroglottography (EGG) Electroglottograph, or EGG, is a device used for the noninvasive measurement of the degree of contact between the vibrating vocal folds during voice production. Electrodes are applied on the surface of the neck so that the EGG records variations in the transverse electrical impedance of the larynx can be measured. 3 months following treatment.
Secondary Acoustic measurement An audio recording of each participant will be obtained. The participant will sustain the "ah" and "ee" vowel three times for the maximum amount of time they are able. They will then read the CAPE-V (Zraick et al., 2011), rainbow passage (Fairbanks, 1960), and describe the cookie theft picture (Borod et al., Boston Diagnostic Aphasia Examination 1980). The samples will then be analyzed using Phonanium, an automated acoustic analysis software. Acoustics will include fundamental frequency, fundamental frequency standard deviation, relative sound pressure level (SPL), SPL standard deviation, cepstral peak prominence smooth (CPPS), harmonic to noise ratio, and noise to harmonic ratio, acoustic voice quality index (AVQI), and spectral slope. pre-intervention
Secondary Acoustic measurement An audio recording of each participant will be obtained. The participant will sustain the "ah" and "ee" vowel three times for the maximum amount of time they are able. They will then read the CAPE-V (Zraick et al., 2011), rainbow passage (Fairbanks, 1960), and describe the cookie theft picture (Borod et al., Boston Diagnostic Aphasia Examination 1980). The samples will then be analyzed using Phonanium, an automated acoustic analysis software. Acoustics will include fundamental frequency, fundamental frequency standard deviation, relative sound pressure level (SPL), SPL standard deviation, cepstral peak prominence smooth (CPPS), harmonic to noise ratio, and noise to harmonic ratio, acoustic voice quality index (AVQI), and spectral slope. 8 weeks post intervention
Secondary Acoustic measurement An audio recording of each participant will be obtained. The participant will sustain the "ah" and "ee" vowel three times for the maximum amount of time they are able. They will then read the CAPE-V (Zraick et al., 2011), rainbow passage (Fairbanks, 1960), and describe the cookie theft picture (Borod et al., Boston Diagnostic Aphasia Examination 1980). The samples will then be analyzed using Phonanium, an automated acoustic analysis software. Acoustics will include fundamental frequency, fundamental frequency standard deviation, relative sound pressure level (SPL), SPL standard deviation, cepstral peak prominence smooth (CPPS), harmonic to noise ratio, and noise to harmonic ratio, acoustic voice quality index (AVQI), and spectral slope. 3 months following treatment.
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